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Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8 Project of the SFB 544

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT00917202
Collaborator
(none)
1
Location
3
Arms

Study Details

Study Description

Brief Summary

Design: Single-centre, controlled study in adults with uncomplicated falciparum malaria in the Nouna Health District, north-western Burkina Faso

Phase: Phase II

Objectives: The primary objective of this trial is to study the efficacy of different methylene blue regimens given to adults with uncomplicated falciparum malaria in an African area of high malaria transmission intensity.

Population: Male adults with uncomplicated malaria from Nouna town.

Sample size: N= 60 (n=20 for each group; three different dosing regimens of MB).

Treatment: The participants in the three different MB regimens will receive orally twice daily 390 mg MB (total daily dose 780mg) over 7,5 or 3 days respectively. Treatment with the five (three) day regimen will only start after all patients of the seven (five) days regimen have been followed up until day 3.

Endpoints: The primary endpoint is the adequate clinical and parasitological response (ACPR) rate on day 28. Secondary endpoints are the number of adverse events (AE) after drug intake until day 28, clinical and parasitological failure rates on day 14 and 28, changes in haemoglobin/haematocrit until day 28, and fever and parasite clearance time.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Official Title:
Efficacy of Methylene Blue for Malaria Treatment in Adults of Burkina Faso: Proof of Principle Study in Semi-Immune Adults of Burkina Faso in the Frame of the A8

Arms and Interventions

Arm Intervention/Treatment
Experimental: MB3

3 days

Drug: Methylenblue
Experimental: MB5

5 days

Drug: Methylenblue
Experimental: MB7

Drug: Methylenblue

Outcome Measures

Primary Outcome Measures

  1. Adequate clinical and parasitolgical response (ACPR) until D 28 []

Secondary Outcome Measures

  1. Early treatment failure (ETF) rate []

  2. Late clinical failure (LCF) rate at D14 and D28 []

  3. Late parasitological failure (LPF) rate at D14 and D28 []

  4. Fever clearance time []

  5. Parasite clearance time []

  6. Change in haematocrit after 2,3,7,14 and 28 days compared to baseline []

  7. Incidence of observed and self-reported non-serious adverse events over the 28 days observation period []

  8. Incidence of serious adverse events over the 28 days observation period []

  9. MB whole blood concentrations (trough concentrations) on day 3,5 or 7 compared to trough concentrations after the first dose []

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 55 Years
Sexes Eligible for Study:
Male
Inclusion Criteria:

  • Male adults (>17 years;<55 years)

  • Uncomplicated malaria caused by P. falciparum

  • Asexual parasites ≥ 1000/µl and ≤ 200 000/µl

  • Axillary temperatures ≥ 37.5°C or history of fever during 48 hours

  • Living in nouna Health District

  • Informed consent

Exclusion Criteria:

  • Complicated or severe malaria

  • Any apparent significant disease

  • Anaemia (haematocrit < 21%)

  • Antimalarial treatment prior to inclusion (last three days)

  • Increased creatinine blood levels

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nouna Health District Nouna Burkina Faso

Sponsors and Collaborators

  • Heidelberg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00917202
Other Study ID Numbers:
  • S-237/2007
First Posted:
Jun 10, 2009
Last Update Posted:
Jun 10, 2009
Last Verified:
Jun 1, 2009
Additional relevant MeSH terms:
Malaria

Study Results

No Results Posted as of Jun 10, 2009